Transcatheter method and system for the delivery of intracorporeal devices

ABSTRACT

A method is provided for the transcatheter delivery of an intracorporeal device and includes establishing a device delivery pathway in a patient. The device delivery pathway extends at least from an entry point into the patient to an exit point from the patient. A method is also provided for the transcatheter retrieval of an intracorporeally implanted device and includes establishing a device delivery pathway in a patient, wherein the device delivery pathway extends at least from an entry point into the patient to an exit point from the patient. A delivery device is also provided for the transcatheter delivery of an intracorporeal device through a device delivery pathway in a patient, the delivery device comprising a catheter comprising a radial separation mechanism, or a delivery catheter and detachably coupling with an intracorporeal device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The application is a Continuation of U.S. patent application Ser. No.15/288,738, filed Oct. 7, 2016, the entire contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to the field of medical devicesand surgery devices. More specifically, the invention relates to atranscatheter system and corresponding devices and methods of treatment.The present invention is particularly useful for the delivery andimplantation into the body of a patient of medical devices, such asmechanical circulatory support devices, but also has a wider variety ofapplications.

The present invention is particularly useful in the context of minimallyinvasive transcatheter and/or percutaneous procedures, such as thosedescribed by the Applicant in US patent application U.S. Ser. No.14/335,125, U.S. Ser. No. 14/335,142, U.S. Ser. No. 14/991,662, U.S.Ser. No. 14/991,675, U.S. Ser. No. 14/984,998 and U.S. Ser. No.14/985,030, and any U.S. published applications for the same, all ofwhich are expressly incorporated herein by reference.

BACKGROUND

Examples of mechanical circulatory support systems (MCS) includeventricular assist devices (VADs). A VAD is a mechanical pumping devicecapable of supporting heart function and blood flow. Specifically, a VADhelps one or both ventricles of the heart to pump blood through thecirculatory system. Left ventricular assist devices (LVAD), rightventricular assist devices (RVAD) and biventricular assist devices(BiVAD) are currently available. Also, circulatory support systems mayinclude cardiopulmonary support (CPS, ECMO), which provide means forblood oxygenation as well as blood pumping. Such devices may be requiredduring, before and/or after heart surgery or to treat severe heartconditions such as heart failure, cardiopulmonary arrest (CPA),ventricular arrhythmia or cardiogenic shock.

Traditionally, VADs are fitted during open-heart surgery through anincision in the chest and the procedure involves puncturing the apex ofthe left ventricle to re-route blood from the ventricle to the aortathrough an external pump. An example of a device used in a surgical VADis HeartMate II™. Such surgical procedures are clearly invasive andunsuitable for weaker and vulnerable patients as they involve a greaterrecovery time and carry the risks of infection and trauma. This isparticularly the case in the treatment of children for whom existingsurgical equipment and devices are comparatively bulkier and moreinvasive, and a reduction of the size of the equipment is oftendifficult if not impossible in view of the equipment and procedureinvolved. Furthermore, these devices require the intervention from ateam of skilled surgical staff in a hospital environment and aretherefore less available and costly.

More recent procedures are non-surgical and involve the insertion of aVAD through a small incision made at the groin of the patient. A popularversion of such so-called percutaneous VAD is the TandemHeart™ device. Atube is introduced through an incision adjacent the groin of the patientand advanced along the femoral vein and inferior vena cava, across theintra-atrial septum and into the left atrium so that oxygenated bloodfrom the left atrium is fed into a pumping device located outside thepatient's body and recirculated through an outflow tube into the femoralartery. Although this device has shown promising results, it onlyprovides short-term support (up to two weeks) and is unsuitable forlong-term treatments. The external pump is bulky and requires thepatient's immobilization for as long as the device is fitted.Furthermore, there is a risk of life-threatening infection around thegroin incision, which remains open during the treatment, and ofconsiderable bleeding from a major artery. In addition, the tube of theTandemHeart™ ends in the left atrium from which blood is pumped out andled outside the patient's body. This type of blood inlet system canpotentially become hindered, if not blocked, if surrounding tissues areaccidentally sucked in, thereby resulting in a loss of efficiency.

Another popular percutaneous VAD is the Impella™ device, which isinserted into the femoral artery and descending aorta. The Impella™device comprises an elongated end, which is implanted across the naturalaortic valve, with a blood inlet placed in the left ventricle and ablood outlet above the aortic valve. A pump circulates blood from theinlet to the outlet. The driveline is externalised through the femoralartery during use and the same limitations apply as with TandemHeart™and other current percutaneous MCS systems. This device is approved toprovide support for up to a week. There is therefore a need for a devicewith reduced risk of infection and bleeding and increased mechanicalstability which can be used as part of a short-term “bridge to recovery”treatment or as a long-term treatment including patient mobilisation. Inaddition, the efficiency of the pump is limited because it is notpossible to insert a pump of the size required to provide a suitableblood flow using percutaneous arterial access. Presently, the problem oflimited pump capacity and duration with percutaneous MCS is solvedeither by inserting larger intracorporeal pumps surgically or bychoosing an extracorporeal pump, with all the potential problems asdescribed above.

Known mechanical circulatory support systems are positioned within thepatient directly though open-heart surgery or indirectly for exampleusing transcatheter methods in which the device is pushed to itsintended position. Such a transcatheter method is described by theApplicant in PCT/EP2015/055578, expressly incorporated herein byreference. These methods involve the implantation of a guide wireextending for example from the patient's groin area, along the femoralvein, up the inferior vena cava into the right atrium, through theatrial wall into the left atrium, through the atrial roof and aorticwall into the aorta, so that the proximal end of the guide wire isoutside the groin area of patient and the distal end is in the aorta.The guide wire assists in the subsequent positioning of catheters and/orsheaths through which the various devices are pushed to their targetpositions.

It has however been observed that the ability to accurately guide andposition the devices is affected by factors such as the target position,for example, where the device is to be moved through or positionedacross anatomical walls, and/or at awkward angles. There may also besome issues with the coupling between the guide wire and the device tobe delivered. Ideally, the guide wire is positioned slidably andcentrally within the device. Depending on the structure of the device,this central positioning is not always achievable and the device ispushed alongside the guide wire in the catheter. This potentially canresult in a less accurate, and therefore less safe, device deliveryprocess.

SUMMARY OF THE INVENTION

It is an object of the invention to at least alleviate theabove-mentioned disadvantages, or to provide an alternative to existingproducts.

According to a first aspect of the invention, there is provided a methodfor the transcatheter delivery of an intracorporeal device comprisingthe step of establishing a device delivery pathway in a patient, whereinsaid device delivery pathway extends at least from an entry point intothe patient to an exit point from the patient.

The present invention effectively provides a delivery system wherein theintracorporeal device and delivery devices can be manipulated and guidedeither from the entry point (also referred to hereinafter as “accesspoint”) or from the exit point or both the entry and exit points.

Conventional delivery systems include at least a guide wire and adelivery sheath which are inserted from an entry point into the body ofthe patient and advanced up to the target delivery site. Theintracorporeal device is then pushed through the delivery sheath to thedelivery site into its target location and position. However, thestructure of the devices, the location of the target delivery siteand/or obstacles in the delivery pathway may render the procedure morecomplicated and it becomes difficult to achieve a highly accuratedelivery and implantation. In the present invention, the devices areinserted through a catheter but can be remotely manipulated from atleast two different sides and angles (i.e. from the access point and theexit point) so that they can be precisely and safely guided intoposition.

The present method is for the delivery and/or implantation of one ormore intracorporeal device, including the delivery and manipulation ofan intracorporeal tool adjacent to or at the target site; the delivery,implantation positioning and/or adjustment of the medical deviceadjacent to or at the target site.

Preferably, the delivery pathway comprises at least one entry point andat least one exit point. Preferably, the entry point and/or the exitpoint is generated by a radial, subclavian, jugular, carotid and/orfemoral access procedure to allow entry into and/or exit from a radial,subclavian, jugular, carotid and/or femoral vein or artery.

In other words, the entry point may be into a radial, subclavian,jugular, carotid or femoral vein or artery and the exit point may beinto a radial, subclavian, jugular, carotid or femoral vein or artery.The entry point and the exit point may be located in the same region,e.g. in the groin area adjacent the femoral vein. However, in practice,optimum improvement has been observed when the entry point is remotefrom the exit point. For example, the entry point may be in thesubclavian area, while the exit point is in the femoral area so thatless pressure is exerted on the patient's anatomy during themanipulation (pushing and/or pulling) of the devices.

An initial percutaneous incision or cut may be performed adjacent theentry and/or exit point, for example in the groin area to access thefemoral vein or artery, in the neck area to access the subclavian orjugular vein or artery, in the arm to access a radial artery or vein. Alarge vein may be preferred to a narrower artery depending on the sizeof the devices used in the procedure. For practical reasons, accessand/or exit from the groin area of the patient may be preferred to, e.g.the neck area of the patient.

Preferably, the device delivery pathway is partly or wholly in thecirculatory system. The circulatory device is ideal for this methodologyas it offers a natural pathway for the delivery of medical devices, suchas ventricular assist devices. Transcatheter delivery techniques areadvantageous in that it allows for the safe manipulation and/or deliveryof medical devices and the patient's surrounding tissues are protectedfrom friction and trauma. The disadvantage is that the dimensions (inparticular the diameter of the delivery catheter) are restricted by thedimensions of the delivery pathways (e.g. the cardio-vascular system).Consequently, the medical devices to be delivered are also limited insize and structure. The present invention is advantageous in that itenables the accurate and safe manipulation and delivery of relativelysmall and complex devices.

Preferably, the delivery site is located in the patient's heart. Thepresent method can be used to deliver known intracorporeal devices toparticular sensitive targets of the patient's body such as the heart,devices as those described in the Applicant's own patent publications.The implantation of such devices often involves the puncture ofanatomical walls, and therefore it is crucial that the devices areimplanted promptly so as to avoid any significant blood loss. On theother hand, any mis-manipulation in the circulatory system could havegrave consequences for the patient. The medical practitioner using thepresent method can easily, accurately, promptly and safely implant thedevices into their target sites.

Preferably, the delivery site is across one or more anatomical walls.The present method is particularly advantageous when applied to complextarget sites and/or target sites which are difficult of access. Forexample, the Applicant's devices can be implanted across two anatomicalwalls, namely the roof of the left atrium and the atrial wall. Theguiding and positioning can be complicated because of the location ofthe target site and the angle of implantation (not always perpendicularto the anatomical walls). It is therefore beneficial to be able tomanipulate the intracorporeal device and/or the delivery device fromeither sides of the delivery site. The ease of manipulation and accuracyis improved.

Preferably, the present method comprises the step of positioning asheath and/or catheter along part or whole of the device deliverypathway.

The present method is a method which involves the delivery of medicaldevices through one or more sheaths and/or catheters. The presentdescription is focused on the transcatheter delivery of medical devicesthrough punctures and/or cuts through the patient's skin. The entrypoint and the exit points preferably involve percutaneous openingsand/or openings through one or more anatomical walls. However, it couldbe envisaged that the entry point and exit point are natural orifices ofthe patient with or without passage through one or more anatomicalwalls.

Preferably, the present method comprises the step of coupling theintracorporeal device to a delivery system, said delivery system beingarranged and configured to extend, in use, at least to the entry pointand to the exit point of the device delivery pathway.

Within the context of this invention, the expression “coupled”preferably means “physically coupled”. The delivery system may be usedto pushed and/or pulled along the delivery pathway using the deliverydevice, for example to its target delivery site. The delivery system mayenable the guiding, delivery and manipulation of the intracorporealdevice through the delivery pathway remotely, i.e. from beyond the entrypoint and the exit point of the device delivery pathway.

Most devices described in the present application are destined forpermanent or semi-permanent implantation therefore, the delivery systemis preferably detachable from the intracorporeal device once the latteris suitably positioned and/or implanted in the patient.

Preferably, the delivery system comprises one delivery device whichextends from the entry point to the exit point of the device deliverypathway. The delivery device is preferably detachably connected to theintracorporeal device so that the delivery device can be removed fromthe patient's body after delivery of the intracorporeal device at thetarget delivery site. This entry-to-exit delivery device enables thepractitioner to push the intracorporeal device e.g. from the accesspoint and/or to pull the intracorporeal device e.g. from the exit point.

For example, the delivery device may comprise a guide wire (orequivalent cable-like or elongate element) which extends along and/orthrough the intracorporeal device. The guide wire may be detachablycoupled to any suitable part of the intracorporeal device. In apreferred embodiment, the guide wire extends through the intracorporealdevice, along the directional axis of the intracorporeal device (i.e.coaxially with the device delivery pathway). This coaxial arrangement ismost advantageous in that it provides the most control of movements asthe intracorporeal device can be pushed and/or pulled from its core.

In another example, the delivery device may comprise a catheter, saidcatheter comprising a radial separation line.

In this embodiment, the intracorporeal device is carried by and/orthrough a catheter which extends along the device delivery pathway. Thecatheter comprises a radial separation line so that the intracorporealdevice can be released by separating the catheter into two parts. Eachseparated catheter part can be pulled out from the patient through theentry and/or the exit point. Preferably, the intracorporeal device isdetachable connected to the catheter. More preferably, theintracorporeal device is positioned adjacent or at the separation line,prior to and during the delivery process. In the latter embodiment, thecatheter slides through the device delivery pathway, until theseparation line is aligned with the target delivery site. The catheterparts can then be separated from each other and the intracorporealdevice released from the delivery catheter.

The separation line is a radial separation line, as opposed to alongitudinal separation line. Preferably, the separation line extendsalong the periphery of the delivery catheter so as to define a circularseparation line. The separation is preferably effected by means whichminimises lateral movements of the catheter when attaching/detaching thetwo catheter parts. A preferred separation line comprises screwing meansand/or a bayonet connecting means. Alternatively or additionally, theseparation line may comprise a tear line, for example a plurality ofperforations and/or a catheter circumference made of thinner materialthickness. natively or additionally, the separation line may compriseother securing means such as tabs, hooks, snap-fit means and the like.

Preferably, the delivery system comprises at least two delivery devices,each delivery device being coupled to an end of the intracorporealdevice.

It has been observed that it is not always possible to position theguide wire coaxially with the delivery pathway, due to the presence ofthe components of the intracorporeal device (e.g. pump, battery or otherinternal components). The proposed alternative is to provide a deliverysystem comprising two separate delivery devices, a first delivery deviceextending from the entry point to the intracorporeal device (i.e. theproximal portion of the device delivery pathway) and a second deliverydevice extending from the device to the exit point (i.e. the distalportion of the device delivery pathway).

Preferably, the first or proximal delivery device is coupled to theproximal end of the intracorporeal device and destined to push theintracorporeal device through the delivery pathway towards the targetsite, and the second or distal delivery device is coupled to the distalend of the intracorporeal device and destined to pull the intracorporealdevice towards the exit point.

Within the context of the invention, the terms “proximal” and “distal”are used relative to the direction of insertion of the delivery device,e.g. the proximal end is the end nearest the access point and the distalend is the end nearest to the exit point; e.g. the end of theintracorporeal device/delivery device closest to the access point is theproximal end and the end of the intracorporeal device/delivery deviceclosest to the exit point is the distal end; e.g. the proximal portionof the device delivery pathway extends at least from the access point tothe intracorporeal device; and the distal portion of the device deliverypathway extends at least from the intracorporeal device to the exitpoint.

In a preferred embodiment, the proximal end of the intracorporeal deviceis connected to the proximal delivery device extracorporeally and thedistal end of the intracorporeal device is connected to the distaldelivery device, extracorporeally. The distal delivery device isinserted first into the patient through the access point, followed bythe intracorporeal device and the proximal delivery device. Once theintracorporeal device is safely delivered, the two delivery devices aredetached and removed from the patient.

In an alternative (less preferred) embodiment, the proximal end of theintracorporeal device is connected to the proximal delivery deviceextracorporeally and the distal end of the intracorporeal device isconnected to the distal delivery device, intracorporeally (or viceversa). The intracorporeal device is inserted through the access pointand pushed through the device delivery pathway using the proximaldelivery device. The distal delivery device is inserted through the exitpoint and pushed through the delivery pathway until it can be connectedintracorporeally to the intracorporeal device.

Preferably, the delivery device comprises an elongate flexible memberand means for coupling an end of said member with the intracorporealdevice. The member is elongated in shape so as to fit within the devicedelivery pathway. In addition, the member should be flexible enough tonavigate through the patient's anatomy but rigid enough so that themember can be used to push and guide the intracorporeal device throughthe device delivery pathway.

Preferably, the elongate flexible member comprises or consists of adelivery catheter or sheath. More preferably, the delivery catheter isdestined to be used as a proximal delivery device. The delivery catheteris coupled to the proximal end of the intracorporeal device so that itis possible to push the intracorporeal device to its target deliverysite.

Preferably, the elongate flexible member comprises or consists of a wireand/or cable. Preferably, the distal delivery device comprises a wire,such as a guide wire. In a preferred embodiment, the proximal deliverydevice comprises a catheter or a cable and the distal delivery devicecomprises a wire. This is because, in practice, more pushing action willbe required in the proximal portion of the delivery pathway, and morepulling action will be required in the distal portion of the deliverypathway.

In another embodiment, the intracorporeal device may comprise a lead orcable, such as a cable for supplying electrical energy to theintracorporeal device. The lead or cable may be detachable ornon-detachable and be used as a delivery device to push, pull and/orguide the intracorporeal device to its target position.

Preferably, the elongate flexible member comprises a portion forreceiving an end of the intracorporeal device. Preferably, the elongateflexible member of the proximal delivery device comprises a portionadapted to receive the proximal end of the intracorporeal device.Preferably, the elongate flexible member of the distal delivery devicecomprises a portion adapted to receive the distal end of theintracorporeal device.

The end of the intracorporeal device may be the most proximal end of thedevice (e.g. for pushing) and/or the distalmost end of the device (e.g.for pulling). It may be a protrusion or extension from the end of theintracorporeal device. It may also be a connector (such as an expandableconnector), a cap or sheath coupled to the end of the intracorporealdevice, a diffusor or any other integral or detachable elements locatedat the end of the intracorporeal device as will be described in furtherdetails below.

In the case of a catheter as delivery device, the receiving portion maybe the distal end of the catheter. In a preferred embodiment, therelative dimensions of the outer periphery of the end of theintracorporeal device and the inner circumference of the catheter aresuch that the catheter can grip the intracorporeal device. Preferably,the inner dimensions of the receiving portion are equal or slightlysmaller than the dimensions of the end of the intracorporeal device.

In an embodiment, the inner surface of the delivery catheter comprisesone or more abutments and/or protrusions arranged and configured so thatan end of the intracorporeal device can sit against said abutments orprotrusions. In another embodiment, it is envisaged that the catheter isdetachably coupled to one or more protrusions extending from the end ofthe intracorporeal device so that the protrusions can fit into one ormore complementary apertures or recesses in the catheter. The deliverycatheter and the intracorporeal device are preferably coupled so thatthe intracorporeal device could also be pulled back towards the entrysite if required.

In the case of a wire or cable as delivery device, the wire or cable maycomprise a snare, hook, loop and/or screw means to couple with the endof the intracorporeal device. The wire or cable may comprise a cup-like,bowl-like or tubular portion capable of receiving the non-expandedconnector arms, diffusor or other expandable element(s) of theintracorporeal device.

Preferably, the receiving portion comprises a means for detachablycoupling with the intracorporeal device. Said detachable coupling meansmay for example comprise retractable tabs, screw means and othersuitable means.

The means for detachably coupling the elongate flexible member with theintracorporeal device may either be secured to the delivery device anddetachably coupled to the intracorporeal device or secured to theintracorporeal device and detachably coupled to the delivery device.

For example, a cap or sheath may be secured to the end of the elongateflexible member (to the distal end of a proximal delivery device or tothe proximal end of a distal delivery device). The cap or sheath may bedetachably coupled to the intracorporeal device so that, during thedelivery process, it partially or fully covers the intracorporeal deviceand can be detached from intracorporeal device after successfuldelivery.

According to a further aspect of the invention, there is provided anintracorporeal device for delivery into a patient, wherein saidintracorporeal device having a proximal end and a distal end andcomprising means for detachably coupling its distal end with atranscatheter delivery device.

The present invention provides an intracorporeal device arranged andconfigured to be connected to a delivery device, in particular adelivery device capable of pulling the intracorporeal device intoposition, and to be detached after delivery, use and/or implantation.

Preferably, the intracorporeal device comprises an integrated expandabledistal component, said distal component being able to changeconfiguration from a delivery configuration to a working configuration.The delivery configuration is preferably a configuration suitable fortranscatheter delivery. The delivery configuration is the configurationin which the intracorporeal device can be coupled to the deliverydevice; whereas in the working configuration, the intracorporeal deviceis detached from the delivery device.

In an embodiment, the delivery configuration may be a foldedconfiguration and the working configuration may be a deployedconfiguration. However, the opposite configurations are also envisagedwithin the scope of the present invention, namely a deployed deliveryconfiguration and a folded delivery configuration. Similarly, thedelivery and working configurations may be retracted and extendedconfigurations. The distal component may also be arranged and configuredto change from a working position into a retrieval configuration.

The distal component may be able to change configuration from a workingconfiguration to a retrieval configuration. In this case, the retrievalconfiguration is preferably a configuration suitable for transcatheterretrieval. The retrieval configuration is the configuration in which theintracorporeal device can be coupled to the retrieval/delivery device;whereas in the working configuration, the intracorporeal device isdetached from the retrieval/delivery device.

Preferably, the integrated distal component is integrally formed withthe intracorporeal device for ease of manufacture. In addition, theintracorporeal device with its integral distal component can bedelivered and implanted safely as a single device. Alternatively, thedistal component is connected to the intracorporeal device. Thisarrangement allows for more versatility and flexibility in the deliveryand implantation procedures. In this embodiment, said connection iseffected prior to insertion into the patient, and more preferably duringthe manufacturing process. Although the distal component can beconnected to the intracorporeal device intracorporeally, it is preferredto minimise the number of manipulations within the patient.

Preferably, the distal component is movably connected to theintracorporeal device so that it can be positioned in a deliveryconfiguration and in a working configuration. For example, the distalcomponent can be hingedly connected to the intracorporeal device or thedistal component comprises or consists of a shape-memory material, whichenables the transition between a delivery configuration and a workingconfiguration.

Preferably, in the working configuration, the integrated expanded distalcomponent is arranged and configured to secure the intracorporeal deviceto one or more anatomical walls. In this embodiment, the distalcomponent serves the dual purpose of detachably coupling theintracorporeal device to a delivery device and to secure theintracorporeal device to its target site.

Preferably, in the working configuration, the integrated expanded distalcomponent is a flow diffusor. In this embodiment, the distal componentserves the dual purpose of detachably coupling the intracorporeal deviceto a delivery device and to improve fluid flow. This is particularlyrelevant when the intracorporeal device comprises a pump. The diffuseris arranged and configured to disperse and spread the fluid exiting fromthe pump in order enhance fluid flow and improve control of the fluidflow.

Within the context of this invention, it is also envisaged that thediffuser be alternatively located within the main body of the pump or atits proximal. However, optimum results are achieved when the diffuserextends from or is coupled to the distal or distalmost end of the pumpso that the flow of fluid is enhanced as it exits the pump. It ispreferred to avoid positioning elements, such as a diffuser, within themain body of the pump, as they could potentially hinder the fluid flowand/or narrow the fluid path within the pump.

Preferably, the integrated expandable distal component comprises aplurality of expandable arms and/or blades. When the integratedexpandable component is a diffusor, the general contour of the deployedarms/blades allows the flow to be enhanced. When the integratedexpandable component is a connector, the arms and/or blade can deployoutwardly to lie against the anatomical wall of the second compartment(i.e. the receiving compartment).

Preferably, the integrated expandable distal component comprises amembrane extending between the arms and/or blades. When the integratedexpandable component is a diffusor, then the membrane improves thediffusor efficiency. The membrane increases the surface area of thediffusor contacting the fluid and therefore increases the efficiency ofthe diffusor. When the integrated expandable component is a connector,the membrane may act as an additional anchor but more importantly as anadditional structural support and protection for the anatomical wall(s).The membrane preferably comprises or consists of a biocompatibleflexible material, which extends between the arms and/or blades (e.g.like an umbrella).

Within the context of this invention, the integral distal component mayconsist of a membrane (i.e. without any arms and/or blades). Thisprovides for a flexible diffuser/connector which is unlikely to damagethe surrounding tissues upon deployment. In this embodiment, themembrane may be made of a shape memory material, or of a flexiblematerial which will adopt the working configuration owing to the fluidflowing out of the pump.

Preferably, the intracorporeal device further comprises means forpushing the integrated expandable distal component into its workingconfiguration. It is envisaged that the integrated expandable distalcomponent may be pushed, pulled and/or otherwise assisted into itsworking configuration. It is also envisaged means for pushing, pullingand/or otherwise assisting the integrated expandable distal componentback into its retrieval/delivery configuration.

In an embodiment, such means comprises an inflatable balloon positionedat the distal end of the intracorporeal device. The intracorporealdevice may comprise a balloon, which is in a deflated state in thedelivery configuration. Upon inflation, the balloon forces thedeployment of (the arms and/or blades of) the integral expandable distalcomponent. The balloon may be positioned centrally with the arms and/orblades of the integrated expandable distal component positionedcircumferentially around the balloon.

The inflatable balloon may be provided as part of the intracorporealdevice or as part of a delivery device. An inflation line in fluidcommunication with the inflatable balloon may be provided as part of theintracorporeal device or as part of a delivery device. The inflatableballoon may be detached from the intracorporeal device and/or thedelivery device after use.

A delivery device may be provided which comprises an elongate flexiblemember and an inflatable balloon at one end thereof, i.e. the end of thedelivery device which is intended to be coupled to the intracorporealdevice. The end of the delivery device comprising the inflatable balloonis coupled to the end of the intracorporeal device comprising theintegral expandable component. Once the intracorporeal device issuitably positioned at the target site, the balloon is inflated so as toassist the deployment of the integral expandable component. When theintegral component is suitably expanded, the delivery device (and itsdeflated balloon) may be detached from the intracorporeal device andremoved from the patient.

In an embodiment, the coupling means may comprise an integral couplingcomponent comprising a cap or a sheath. In this instance, the cap orsheath is integrally formed with the intracorporeal device, preferablyadjacent or at the distal end of the device. More preferably, the cap orsheath is arranged and configured such that it partially or whollysurrounds a distal expandable component. One of its functions is to keepthe expandable component in a non-expanded configuration. For example,if the expandable component comprises plurality of expandablearms/blades, these would be kept together in a delivery configurationunder the cap or sheath. In order to release the expandable arms/blades,the cap/sheath may be removed in any suitable manner, for example tornor pulled back.

Preferably, the intracorporeal device comprises a detachable couplingcomponent, said distal component being able to be expanded from adelivery configuration to a working configuration. In this embodiment,“detachable component” means that the component is attached to theintracorporeal device before and during the delivery process and can bedetached after delivery/implantation. “Coupling component” means thatthe component is destined to couple the intracorporeal device to thedelivery device. Thus, in this embodiment, the coupling means is not anintegrated distal end, but can be detached from the intracorporealdevice.

Preferably, the detachable component comprises a cap and/or a sheath,similar to the integral cap or sheath, but which in this embodiment isdetachable. Upon delivery of the intracorporeal device, the cap/sheathcan be detached from the intracorporeal device, thereby releasing thearms/blades into a working configuration, and be removed from thepatient.

The detachable component may be attached to the intracorporeal device byany suitable means, including screw means, tabs, hooks, tearline and thelike.

Preferably, the detachable coupling component is secured to the deliverydevice. The cap or sheath can be detachably coupled to theintracorporeal device but secured to the delivery device. Prior to orduring the delivery process, the intracorporeal device is coupled to adelivery device, more specifically the distal component of theintracorporeal device is coupled to a cap or sheath. The cap or sheathis secured to or integrally formed with the delivery device. Once theintracorporeal device is suitably delivered and/or implanted, the cap orsheath is detached from the distal component of the intracorporealdevice and removed by pulling the delivery device out of the patient.

In another embodiment, the detachable coupling component is secured tothe delivery device. During the delivery process, the coupling componentsecures the intracorporeal device to the delivery device. Once theintracorporeal device is suitably positioned, the detachment of thecoupling component enables the integral expandable component to deployinto its working configuration. For example, the integral expandablecomponent may comprise a plurality of arms which are hingedly connectedto the distal end of the intracorporeal device. The arms may besubstantially L-shaped so that one end of the arms can be deployedoutwardly, whilst the other end is arranged and configured to beinterlocked into a coupling position with the delivery device or to beused as a lever by pulling the delivery device to deploy the arms into aworking position.

According to another aspect of the invention, there is provided adelivery device for the transcatheter delivery of an intracorporealdevice through a device delivery pathway in a patient, said deliverydevice comprising a catheter comprising a radial separation mechanism.

According to another aspect of the invention, there is provided adelivery device for the transcatheter delivery of an intracorporealdevice through a device delivery pathway in a patient, said deliverydevice comprising a delivery catheter and means for detachably couplingwith an intracorporeal device. In a preferred embodiment, the deliverydevice further comprises means for assisting the implantation of theintracorporeal device to its target delivery site. Preferably, saidmeans comprises an inflatable balloon.

According to another aspect of the invention, there is provided a systemfor the transcatheter delivery of an intracorporeal device through adevice delivery pathway in a patient, said system comprising anintracorporeal device as described above and a delivery device asdescribe above.

Within the context of this invention, the term “intracorporeal” meansinside the body of a patient. For example, an intracorporeal device is adevice which is destined for use and/or implantation inside the body ofa patient. The term “extracorporeal” means outside the body of apatient. For example, an extracorporeal connection is a connection whichtakes place outside the body of the patient. It is also envisaged that adevice comprises an intracorporeal part and an extracorporeal part.

The term “transcatheter” includes percutaneous, trans-atrial,trans-femoral (through the leg), trans-apical (in the chest between theribs), and trans-aortic (in the upper chest). Preferred embodiments arepercutaneous systems, devices and methods.

The term “percutaneous” is used with reference to any medical procedurewhere access to inner organs or other tissue is done through a punctureand/or incision through the skin (and/or the vascular system) forexample into the circulatory system, as opposed to an open surgeryprocedure. Thus, a percutaneous method involves the percutaneousdelivery of elements and may involve an incision (for example with ascalpel) to enable percutaneous delivery. In a preferred embodiment, themethod provides transcardiovascular delivery of one or more devices forestablishing fluid communication between anatomically separate butadjacent thoracic organs, after gaining access to the vascular system bya puncture or incision. The puncture or incision may be made at varioussites where intravascular access is possible, for example in the groin,axilla, chest or abdomen.

Within the context of the invention, any of the devices and systemsdescribed herein can be used with any of the methods described herein.

The devices, systems and methods according to the present invention havebeen described above in connection to the delivery of an intracorporealdevice to an intracorporeal target site. However, it is envisaged withinthe context of the invention that the devices, systems and methodsaccording to the present invention are used for the purpose ofretrieving an intracorporeal device from its implantation site.

LIST OF EMBODIMENTS

The following is a non-limiting list of potential embodiments of thepresent invention, set forth as embodiment groups (each an“Embodiment”). Additional embodiments of the invention are possible, asset forth throughout this specification and the drawings.

Embodiment 1

A method for the transcatheter delivery of an intracorporeal devicecomprising the step of establishing a device delivery pathway in apatient, wherein said device delivery pathway extends at least from anentry point into the patient to an exit point from the patient.

Embodiment 2

The method according to Embodiment 1 wherein the entry point and/or theexit point is generated by a radial, subclavian, jugular, carotid,and/or femoral access procedure to allow entry into and/or exit from aradial, subclavian, carotid, jugular and/or femoral vein or artery.

Embodiment 3

The method according to Embodiment 1 or 2, wherein the device deliverypathway is partly or wholly in the circulatory system.

Embodiment 4

The method according to any preceding Embodiment, wherein the deliverysite is located in the patient's heart.

Embodiment 5

The method according to any preceding Embodiment, wherein the deliverysite is across one or more anatomical walls.

Embodiment 6

The method according to any preceding Embodiment, comprising the step ofpositioning a sheath and/or catheter along part or whole of the devicedelivery pathway.

Embodiment 7

The method according to any preceding Embodiment, comprising the step ofcoupling the intracorporeal device to a delivery system, said deliverysystem being arranged and configured to extend, in use, at least to theentry point and to the exit point of the device delivery pathway.

Embodiment 8

The method according to Embodiment 7, wherein the delivery systemcomprises one delivery device which extends from the entry point to theexit point of the device delivery pathway.

Embodiment 9

The method according to Embodiment 7, wherein the delivery systemcomprises at least two delivery devices, each delivery device beingcoupled to an end of the intracorporeal device.

Embodiment 10

The method according to any one of Embodiments 7 to 9, wherein thedelivery device comprises an elongate flexible member and means forcoupling an end of said member with the intracorporeal device.

Embodiment 11

The method according to Embodiment 10, wherein the elongate flexiblemember comprises or consists of a delivery catheter.

Embodiment 12

The method according to Embodiment 10, wherein the elongate flexiblemember comprises or consists of a wire and/or cable.

Embodiment 13

The method according to any one of Embodiments 10 to 12, wherein theelongate flexible member comprises a portion for receiving an end of theintracorporeal device.

Embodiment 14

The method according to Embodiment 8, wherein the delivery devicecomprises a catheter, said catheter comprising a radial separation line.

Embodiment 15

A method for the transcatheter retrieval of an intracorporeallyimplanted device comprising the step of establishing a device deliverypathway in a patient, wherein said device delivery pathway extends atleast from an entry point into the patient to an exit point from thepatient.

Embodiment 16

A delivery device for the transcatheter delivery of an intracorporealdevice through a device delivery pathway in a patient, said deliverydevice comprising a catheter comprising a radial separation mechanism.

Embodiment 17

A delivery device for the transcatheter delivery of an intracorporealdevice through a device delivery pathway in a patient, said deliverydevice comprising a delivery catheter and means for detachably couplingwith an intracorporeal device.

Embodiment 18

The delivery device according to Embodiment 17, comprising an inflatableballoon.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further described with reference to the drawingsand figures, in which

FIG. 1 illustrates a transcatheter delivery method and system accordingto the present invention;

FIG. 2 illustrates an anterior device delivery pathway;

FIG. 3 illustrates a posterior device delivery pathway;

FIGS. 4a to 4c are schematic representations of an intracorporeal deviceaccording to the present invention;

FIG. 5 is a schematic representation of an intracorporeal device anddelivery devices according to the present invention;

FIG. 6 is a schematic representation of an intracorporeal device anddelivery devices according to the present invention;

FIGS. 7a and 7b are schematic representations of a first deploymentmechanism for use in the present invention;

FIGS. 8a and 8b are schematic representations of a second deploymentmechanism for use in the present invention;

FIG. 9 is a schematic representation of an intracorporeal device anddelivery device according to the present invention;

FIGS. 10a to 10d are schematic representations of delivery devicesaccording to the present invention;

FIGS. 11a to 11c are schematic representations of delivery devicesaccording to the present invention;

FIGS. 12a and 12b are schematic representations of a catheter or sheathwith a radial separation line; and

FIG. 13 and FIGS. 14a to 14 c are schematic representations of adeployment process in a method according to the present invention.

FIGS. 15a to 15d illustrate the delivery and implantation process of ananchor using a delivery catheter with a radial separation mechanism.

DETAILED DESCRIPTION

The invention is described by way of examples, which are provided forillustrative purposes only. These examples should not be constructed asintending to limit the scope of protection that is defined in theclaims. For example, although various aspects have been described withrespect to the heart and the circulatory system, this is not intended tobe limiting, and is merely performed to provide an example ofimplementation. Aspects disclosed herein may be utilised in any medicaldevice implantable within the human body, for example in thecardiovascular system, respiratory system, gastric system, neurologicalsystem, and the like, some examples including implantable pumps and drugdelivery pumps. As used herein, the term “means” can be equivalentlyexpressed as, or substituted with, any of the following terms: device,apparatus, structure, part, sub-part, assembly, sub-assembly, machine,mechanism, article, medium, material, applicant, equipment, system, bodyor similar wording.

Referring to FIG. 1, there is illustrated a transcatheter deliverysystem and method according to the present invention including aintracorporeal device delivery pathway 1 extending from an entry point 2into a patient to an exit point 3 from the patient. In thistranscatheter method, an intracorporeal device 4 is delivered to atarget site 5 through a delivery catheter or sheath 6. Theintracorporeal device 1 is detachably connected to a device deliverysystem comprising a first delivery device 6 extendable at least betweenthe entry point 2 to the proximal end of the intracorporeal device 4 anda second delivery device 7 extendable at least between the distal end ofthe intracorporeal device 4 and the exit point 3. The proximal end P andthe distal end D are defined relative to the direction of insertion ofthe delivery device, i.e. in the direction of the entry point towardsthe exit point.

In the embodiment shown in FIG. 1, access into the patient's body iscreated through a puncture or incision in the groin area and the entrypoint 2 is into the femoral vein or artery. Exit from the patient's bodyis created through a puncture or incision in the neck area with an exitpoint 3 from the jugular vein or in the clavicle area with an exit point3 from a subclavian artery.

The present invention will be described in the context of theimplantation of an intracorporeal device 4 for establishing fluidcommunication between two anatomical compartments for example the leftatrium LA and the aorta AO, wherein the target implantation site isacross two separate anatomical walls 10, 11, in this example the roof ofthe left atrium and the aortic wall. However, it is understood that thepresent invention can be used for different procedures at differenttarget sites.

The device delivery pathway 1 extends at least between the entry point 2and the exit point 3, but can also extend beyond the entry point 2 andthe exit point 3. It is known to insert a device for intracorporeal useand/or implantation via the femoral, subclavian or jugular access. Inthese techniques, the device is inserted and pushed through thecirculatory system up to the delivery site, for example the heart for aventricular assist device. In the Applicant's own PCT/EP2015/055578, thedevices are pushed through a puncture in the atrial septum, thendelivered across the roof of the left atrium and the aortic wall in aso-called anterior delivery method (FIG. 2). It is also possible toinsert a device via a posterior pathway (FIG. 3). For example, thedevices can be inserted through the descending aorta into the leftatrium and then delivered across the roof of the left atrium and theaortic wall.

In U.S. Ser. No. 14/991,662 and U.S. Ser. No. 14/991,675, the Applicantdescribes a connector comprising a neck, a first set of arms extendingfrom a first end of the neck and a second set of arms extending from thesecond end of the neck. In an anterior delivery method, the deliverysheath passes through the atrial septum to the left atrium and into theaorta. In a posterior delivery method, the delivery sheath passesthrough the wall of the ascending aorta and the roof of the left atrium,so that the first arms deploy and lay against the roof of the leftatrium as they exit the catheter, followed by the second arms againstthe wall of the ascending aorta. The posterior pathway is advantageousin that it presents fewer obstacles (e.g. anatomical walls to bepunctured, proximity to the coronary artery and mitral and aortic valvein the anterior pathway). Depending on the structure and dimensions ofthe intracorporeal device 4, it can sometimes be difficult in theanterior method to accurately achieve the required positions and angles;whereas the posterior pathway provides more room to manoeuver so thatlarger devices can be implanted. Finally, the anterior pathway is morecommonly used for physiological reasons but there is a risk of potentialblood clots and strokes. This risk can be minimised by insertingposteriorly. The present invention can make use of delivery pathwayssuch as anterior and posterior pathways.

The intracorporeal device 4 according to the present invention has aproximal end 4P and a distal end 4D, also defined relative to thedirection of insertion, and means for detachably coupling its distal end4D with a transcatheter delivery device so that the intracorporealdevice 4 can be pulled in the direction of insertion. As discussedabove, known methods involve pushing the intracorporeal device through adelivery sheath to the target site 5. By contrast, the method accordingto the present invention alternatively or additionally involves pullingthe intracorporeal device 4 to the target site; and the intracorporealdevice 4 according to the present invention comprises means for beingpulled to the target site 5. Most preferably, the method according tothe present invention enables the practitioner to both push and pull theintracorporeal device 4 (so that the intracorporeal device can bemanipulated from both proximal and distal ends or from both the entryand the exit points into the patient); and the intracorporeal device 4according to the present invention comprises means for being both pushedand pulled. This may be achieved by a number of differentinterconnections between the intracorporeal device 4 and thetranscatheter delivery device. Within the context of the presentinvention, the intracorporeal device 4 may be inserted through and/ormanipulated from a number of different access and exit points. Theintracorporeal device 4 may be inserted forward or backward, relative toits target in-use position. Therefore, the various interconnectionsdescribed herein may be used either at the distal end of theintracorporeal device 4, or both at the distal end and the proximal endof the intracorporeal device 4 (i.e. distal end 4D of the intracorporealdevice 4 to proximal end of second delivery device 7; and proximal end4P of the intracorporeal device 4 to distal end of the first deliverydevice 6). When the intracorporeal device 4 comprises an interconnectionat its distal end and another interconnection at its proximal end, bothinterconnections can be the same or different. Similarly, the deliverydevices described herein may be used as a first proximal delivery device6 and/or as a second distal delivery device 7. The device deliverysystem described in this embodiment may be referred to as “Arterial toVenous steerable Pump Delivery” (AVPD) system.

In an embodiment illustrated in FIGS. 4a to 4c the intracorporeal device4 comprises a housing with a proximal end 4P and a distal end 4D. Thehousing comprises a pump to regulate fluid flow between the left atriumLA and the aorta AO. The intracorporeal device 4 comprises a pluralityof arms or blades 8 which are preferably integrally formed or secured toits distal end 4D. In a delivery (or retrieval) configuration asillustrated in FIG. 4a , the distal ends of the arms 8 are gatheredtogether so that the arms 8 are folded and the device 4 fits in adelivery catheter. In a working configuration as illustrated in FIGS. 4band 4c , the arms 8 are released and deployed so that the unfolded arms8 can rest partially or wholly against an anatomical wall. In thisembodiment, the arms 8 serve the dual purpose of connecting theintracorporeal device 4 to the delivery device and acting as a connectoror anchor. This intracorporeal device 4 is particularly suited to atarget site across one or more anatomical walls 10, 11, as the integralarms 8 can secure the intracorporeal device 4 across said anatomicalwalls 10, 11, and support and protect said anatomical walls 10, 11. Theplurality of arms 8 may comprise a set of short arms and a set of longarms (as described in the Applicant's U.S. Ser. No. 14/991,662 and U.S.Ser. No. 14/991,675) to ensure a smooth and atraumatic release andimplantation of the intracorporeal device 4.

In FIG. 5, the distal delivery device 7 intended to pull theintracorporeal device 4 comprises an elongate flexible member, in thiscase a wire or cable 12 and a proximal portion for receiving the distalend of the arms 8. The wire or cable 12 is rigid enough to enableaccurate guiding of the intracorporeal device 4, but flexible enough toavoid injury to the patient. The receiving portion 13 is cup- orbowl-shaped. The receiving portion 13 is preferably detachably connectedto the arms 8, so as to be attached during delivery and detached aftersuccessful delivery. The receiving portion 13 may comprise internalconnection means for detachably connecting to the arms 4. Upondetachment of the receiving portion 13 from the arms 8, the arms 8 arereleased and can change from their delivery configuration to theirworking configuration. The arms 8 may be retained within the receivingportion 13 through tension. The arms 8 may comprise eyelets 9 tofacilitate connection to the receiving portion 13. The eyelets alsoincrease the surface area of the arms 8 and provide additional supportto the anatomical walls 10, 11.

In FIG. 6, the distal delivery device 7 comprises an elongate flexiblemember, in this case a wire or cable 12, a receiving portion 13 and aproximal sheath or cap 14. The sheath or cap 14 is arranged andconfigured to cover the folded arms 8 during the delivery process. Thesheath or cap 14 is made of a bio-compatible material such as amembrane, fabric of the like. The sheath or cap 14 is secured either tothe distal delivery device 7 or to the intracorporeal device 4. Thesheath or cap 14 may be detachably connected to the distal deliverydevice 7 or to the intracorporeal device 4. For example, the sheath orcap 14 may be made of an elastic or resilient material so as to beconnected to the distal end of the intracorporeal device 4; the sheathor cap 14 may be made of a tearable material or may comprise a suitablypositioned tear line; the sheath or cap 14 and the distal deliverydevice 7 or to the intracorporeal device 4 may comprises complementarydetachable connections means, such as tabs, screwing means, hooks,snares and the like. The distal delivery device 7 may or may notcomprise a receiving portion 13. The distal ends of the arms 8 may bedetachably connected to the elongate flexible member 12 by any othersuitable means.

In FIG. 7a , the intracorporeal device 4 comprises an inflatable balloon15 intended to assist the deployment of arms 8. The balloon 15 isarranged and configured so that, upon inflation, the balloon 15 pushesthe arms 8 outwardly into their working configuration. Theintracorporeal device preferably comprises an inflation line (not shown)for inflating the balloon 15. Alternatively, the distal delivery device7 comprises an elongate flexible member 12 and an inflatable balloon 15intended to assist the deployment of arms 8. The distal delivery device7 may comprise a separate inflation line or an integrated inflationline, with an inflation port 16 into the balloon 15. It could also beenvisaged that the proximal delivery device 6 comprises the inflationballoon 15 and an inflation line. It is preferred that the balloon 15 issecured to the distal or proximal delivery device 6,7 so that theballoon 15 can be detached from the intracorporeal device 14 and removedfrom the patient together with the delivery device after successfuldelivery of the intracorporeal device 4.

FIGS. 8a and 8b illustrate a different means for assisting thedeployment of the arms 8. The arms 8 are hingedly connected to theintracorporeal device 4. The distal delivery device 7 comprises means 17for pivoting the arms 8 about the hinges into their working position.

FIG. 9 illustrates an intracorporeal device 4 comprising a housing asdescribed above and a distal flow diffusor 18. The diffusor 18 maycomprise a plurality of arms or blades 8. In this embodiment, the arms 8serve the dual purpose of connecting the intracorporeal device 4 to thedelivery device and acting as flow diffusor to improve and/or enhancethe fluid flow from the pump. Preferably, the diffusor 18 comprises aplurality of blades with an optional membrane extending between saidblades 8. Alternatively, the diffusor 18 may comprise a membrane and bedevoid of arms and blades. The diffusor 18 may be connected to thedistal delivery device 7 as described above in connection to theconnector arms, and be deployed in the same manner.

In the method according to the present invention, the intracorporealdevice 4 need not comprise distal expandable arms or blades 8 asdescribed above as long as it comprises means for interconnecting with adelivery device 7 so as to be pulled towards the target site 4 ortowards the exit point 3. The interconnection between the intracorporealdevice 4 may comprise means such one or more tabs, screwing means,hooks, loops and/or snares and the like.

Turning now to the interconnection between the proximal end 4P of theintracorporeal device 4 and the second proximal delivery device 6, FIGS.10a to 10d show examples of delivery devices 6 comprising a deliverycatheter. The delivery catheter 6 may be made of a biocompatibleflexible material. The inner diameter of the delivery catheter 6 may beequal or smaller than the outer diameter of the proximal end 4P of theintracorporeal device 4 so as to retain the intracorporeal device 4therein. This may be achieved by using a resilient material (FIG. 10a )or by including a portion of narrower diameter (FIG. 10b ). The delivercatheter 6 may comprise one or more ribs or tabs to act as an abutmentto assist the pushing of the intracorporeal device 4 (FIG. 10c ). Thedelivery catheter 6 and the intracorporeal device 4 may comprisecomplementary connection means, such as screwing means (FIG. 10d ).

FIGS. 11a to 11c show examples of delivery devices 6 comprising a wireor cable. When the primary purpose of the delivery device 6 is to pushthe intracorporeal device 4, then a cable is preferred as it providessuitable rigidity and support. The cable 6 may be integrally formed orsecured to the proximal end of the intracorporeal device 4 (FIG. 11a ),and may for example be a cable for providing the intracorporeal device 4with electrical energy. The cable 6 may be detachably connected to theintracorporeal device 4, for example using screwing means (FIG. 11b ),tabs (FIG. 11c ), hooks and the like. The wire/cable-intracorporealdevice combination may be delivered through a delivery catheter orsheath. If other components or intracorporeal devices (such as drivelineor battery) are required, then they may be delivered to the target siteusing the same delivery catheter or sheath.

Another device 19 for use in the method according to the presentinvention is illustrated in FIGS. 12a and 12b . The device 19 comprisesa catheter or sheath with at least one radial separation line 20 so thatthe catheter 19 can be separated into two portions 19 a and 19 b. Theradial separation line 19 may comprise a tear line, complementaryscrewing means, complementary tabs, ribs, hooks and the like. Thisdevice 19 is useful as an outer delivery sheath, such as one used todefine the device delivery pathway 6. The device 19 may alternatively beused as a device 6,7 for the delivery of intracorporeal device 4. Eachportion 19 a and 19 b may be detachably connected to the intracorporealdevice 4 during the delivery process and disconnected after successfuldelivery.

Within the context of the invention, it is envisaged that either or bothdelivery devices 6,7 comprise means for remotely controlling theinterconnection between the delivery device(s) and the intracorporealdevice 4, to remotely guide and manipulate the intracorporeal deviceand/or to remotely guide and manipulate the end of the deliverydevice(s) inside the patient.

A method according to the present invention will now be described by wayof example with reference to the anterior delivery and implantation ofan intracorporeal device 4 for fluid connection between the left atriumLA and the aorta AO, with target implantation site across the roof ofthe left atrium and the aortic wall.

The first step is the insertion of a guide wire, which can be carriedout by means known in the art. An incision or puncture is performed inthe groin area of the patient, adjacent the femoral vein or artery. Aguide wire is advanced along the femoral artery and up the inferior venacava and enters the right atrium. A septal puncture between the rightand left atrium can also be carried out by means known in the art. Apuncture device such as one described in the Applicant'sPCT/EP2015/055578 is used to push the left atrium and the aortic wallagainst each other and puncture both walls.

Known visualisation techniques such as X-ray, fluoroscopy,echocardiography and ultrasound techniques may be used. The inventorshave also discovered that techniques for mapping the puncture site canbe crucial in hindered and complex target sites such as the heart. Thisis particularly true when the target site is across two separateanatomical walls, as the puncture wire have a tendency to deflect fromthe wall surface is not positioned centrally and at a specific angle.The preferred mapping techniques in the context of the present inventioninclude Intra-Cardiac Echochardiography techniques (ICE), Trans-CardiacEchochardiography (TCE), Trans-Thoracic Echochardiography (TTE),Computer Tomography (CT), Magnetic Resonance Imaging (MRI) techniques.

Any of the delivery devices and/or delivery sheath can comprise magnetor magnetic means to accurately position the devices and surround thepuncture site. For example, the distal end of the proximal deliverydevice in the first anatomical compartment and the proximal end of thedistal delivery device in the second anatomical compartment may havemagnetic coupling or other coupling means so that the two ends meetaccurately with each other on either side of the anatomical walls to bepunctured.

Once the punctures have been carried out, the guide wire is advancedinto the aorta into a subclavian artery where a further puncture is madein the arterial wall. The guide wire exits the patient's body in thepatient's neck area. Using methods and devices known in the art, anouter delivery sheath is positioned around the guide wire and along thedevice delivery pathway 6. In a preferred embodiment, the outer deliverysheath is a device 19 as shown in FIG. 12 and the radial separation line20 is positioned adjacent the target site 5, in this case the roof ofthe left atrium and the aortic wall. The delivery pathway 6 between anentry point 2 and exit point 3 is established.

Outside the patient's body, the intracorporeal device 4 is prepared forinsertion. The distal end 4D of the intracorporeal device 4 comprises aplurality of arms 8. The distal delivery device 7 comprises a wire 12and a tubular receiving portion 13. The distal end of the arms 8 arereceived in the receiving portion 13 of a distal delivery device 7. In apreferred embodiment, a wire 21 comprising an inflatable balloon 15 ispre-loaded into the distal delivery device 7. The inflatable balloon 15comprises means for detachably connecting with the distal end of theintracorporeal device 4, in this case screw means 22. The proximaldelivery device comprises a catheter 6. The distal end of the catheteris connected to the proximal end 4P of the intracorporeal device 4 forexample by means of complementary screw means. The intracorporeal device4 is connected to both delivery devices 6,7 and ready for insertion.

The wire 12 of the distal delivery device 6 is inserted first throughthe entry point 2 into the outer delivery sheath 19 and pushed forwarduntil it exits the patient at exit point 3. The intracorporeal device 4is advanced along the delivery pathway 6 through the outer sheath 19 bypushing using the proximal delivery device 6 and/or pulling using thedistal delivery device 7, until it reaches the target delivery site 5.

In an alternative embodiment, the intracorporeal device 4 is connected(extracorporeally) to the proximal delivery device 6, inserted throughthe entry point 2 and advanced along the delivery pathway 6 to thetarget delivery site 5. The distal delivery device 7 is inserted throughthe exit point 3 and advanced along the delivery pathway 6 to the targetdelivery site 5, where it is intracorporeally connected to theintracorporeal device 4. However, the extracorporeal connection of theintracorporeal device 4 to both distal and proximal delivery devices ispreferred, as it minimised the number of manipulation within thepatient, and therefore the risk of accidents.

The intracorporeal device 4 is accurately and safely guided andpositioned across the anatomical walls (i.e. roof of the left atrium andaortic wall) using the distal delivery device 7 and the proximaldelivery device 6. If the outer delivery sheath is a sheath as shown inFIG. 12, then sheath distal and proximal portions 19 a and 19 b areseparate from each other and the distal portion 19 a is pulled out ofthe patient's body. If the outer delivery sheath is a standard one-piecedelivery sheath, then it is pulled back towards the entry point 2, untilits distal end is adjacent the target delivery site 5. Theintracorporeal device 4 is now ready for implantation (FIG. 13).

With reference to FIGS. 14a to 14c , the delivery device 7 is pulledback towards the exit point 3 so as to release the ends of the arms 8 ofthe intracorporeal device 4 (FIG. 14a ). The inflatable balloon 15 isinflated using the inflation line (not shown) so as to assist thedeployment of the arms 8 (FIG. 14b ). The arms 8 deploy until they reachtheir working position, lying against the aortic wall 10. The balloon 15is deflated and detached from the intracorporeal device 4 by unscrewingscrewing means 22. The distal delivery device 7 may now be removed frompatient through exit point 3. The proximal delivery device 6 may also bedetached from the intracorporeal device 4 and removed from the patientthrough entry point.

The present invention has been described in connection to a devicedelivery process. It is however envisaged that the present invention maybe used in connection to a device retrieval process. In the retrievalprocess, the guide wire and outer sheath are positioned as describedabove in connection to the delivery process. The distal deliveryretrieval device 7 (now distal retrieval device 7) is inserted throughthe exit point 3 and connected to the distal end 4D of theintracorporeal device 4. The proximal delivery device 7 (now proximalretrieval device 6) is inserted through the entry point 2 and connectedto the proximal end 4D of the intracorporeal device 4. Theintracorporeal device 4 can be accurately and safely dislodged from theimplantation position, and removed from the patient's body.

In another embodiment, the intracorporeal device 4 may be a connector 40as described in the Applicant's PCT/EP2015/055578, comprising a neck 41for fluid passage between two compartments LA, AO, a first set of arms 8a destined to lie against the aortic wall 10 in a working configuration,and a second set of arms 8 b destined to lie against the roof of theleft atrium 11 in a working configuration. This connector 40 isparticularly useful when used to anchor a second intracorporeal devicesuch as the pump described above, where said pump does not comprise anintegral set of arms (connector).

With reference to FIGS. 15a to 15d , the anchor 40 is delivered to thetarget sire 5 through a delivery catheter 19 with a radial separationmechanism 20. The neck 41 and the separation line 20 are positionedacross the anatomical walls 10, 11 (FIG. 15a ). The catheter portions 19a and 19 b are separated from each other (FIG. 15b ). Proximal catheterportion 19 b is pulled back so as to release the atrial arms 8 b. Theatrial arms 8 b expand to lie into their working configuration againstthe roof of the left atrium 11. Then distal catheter portion 19 a ispulled back so as to release the aortic arms 8 a. The aortic arms 8 aexpand to lie into their working configuration against the aortic wall10. The connector 40 is now implanted into its working configuration andthe intracorporeal device 4 (e.g. pump) can now be delivered using themethod and devices according to the present invention.

In the method according to the present invention, the anatomical wallsare preferably held together by a connector (integral or separateconnector) so as to minimise the risk of blood leakage into theinter-compartmental space between the left atrium and the aorta. Inaddition, the use of the connector is also advantageous in that thewalls are less likely to slide or move during the process of implantingan intracorporeal device 4 across the two anatomical walls. Where theintracorporeal device 4 is to be implanted without a connector 40(integral or separate connector), preferably the method comprises theadditional step of suturing and/or stapling the two anatomical walls toeach other by means known in the art. Thus, no additional connectordevice (integral or separate connector) is required.

Thus, from the above description, it can be seen that the presentinvention provides versatile and accurate method for the delivery orretrieval of an intracorporeal device. The present invention alsoprovides systems and devices for use in said method.

1. An intracorporeal device for delivery into a patient, wherein saidintracorporeal device having a proximal end and a distal end andcomprising means for detachably coupling its distal end with atranscatheter delivery device.
 2. The intracorporeal device according toclaim 1, comprising an integrated expandable distal component, saiddistal component being able to be expanded from a delivery configurationto a working configuration.
 3. The intracorporeal device according toclaim 2, wherein, in the working configuration, the integrated expandeddistal component is arranged and configured to secure the intracorporealdevice to one or more anatomical walls.
 4. The intracorporeal deviceaccording to claim 2, wherein, in the working configuration, theintegrated expanded distal component is a flow diffusor.
 5. Theintracorporeal device according to claim 2, wherein the integratedexpandable distal component comprises a plurality of expandable armsand/or blades.
 6. The intracorporeal device according to claim 5,wherein the integrated expandable distal component comprises a membraneextending between the arms and/or blades.
 7. The intracorporeal deviceaccording to claim 2, further comprising means for assisting theexpansion of the integrated expandable distal component into its workingconfiguration.
 8. The intracorporeal device according to claim 7,wherein the assisting means comprises an inflatable balloon.
 9. Theintracorporeal device according to claim 1, comprising a detachablecoupling component, said distal component being able to be expand from adelivery configuration to a working configuration.
 10. Theintracorporeal device according to claim 9, wherein the detachablecomponent comprises a cap and/or a sheath.
 11. The intracorporeal deviceaccording to claim 9, wherein the detachable component is coupled to thedelivery device.
 12. The intracorporeal device according to claim 1,comprising an integrated expandable distal component, said distalcomponent being able to be retracted from a working configuration to aretrieval configuration.
 13. The intracorporeal device according toclaim 12, wherein, in the retrieval configuration, the integratedexpanded distal component is arranged and configured to release theintracorporeal device from said one or more anatomical walls.
 14. Theintracorporeal device according to claim 1, comprising a detachablecoupling component, said distal component being able to be retractedfrom a working configuration to a retrieval configuration.